Nabriva Therapeutics plc (NASDAQ: NBRV) Receives marketing Approval for IV and oral Lefamulin Formulations in China

Nabriva Therapeutics plc (NASDAQ: NBRV)  has announced that The Chinese Centre for Drug  Evaluation has accepted its partner Sumitomo Pharmaceuticals’ new drug application for marketing intravenous and oral lefamulin formulations for community-acquired pneumonia treatment in China.

Sumitomo to develop and market lefamulin in China

In May 2021, Nabriva and Sumitomo Pharmaceuticals (Suzhou), a Chinese subsidiary of Sumitomo Dainippon Pharma Co., Ltd., signed an agreement for the development and marketing of lefamulin in the greater China region. Once approved, lefamulin is projected to become a novel, first-in-class medication for Chinese CAP patients.

CEO of Nabriva Ted Schroeder said, “We are working collaboratively with Sumitomo Pharmaceuticals (Suzhou) Co., Ltd., throughout the health authority review. This filing brings Nabriva and Sumitomo Pharmaceuticals (Suzhou) Co., Ltd. one step closer to their goal of offering lefamulin to patients with CAP in China. This is the 6th global filing for lefamulin. To date there have been 4 approvals and two applications pending review.”

Nabriva makes lefamulin available in a 10-count oral pack 

Recently Nabriva announced the availability of lefamulin in a 10-count oral pack in the US  via leading specialty distributors. Lefamulin is the first IV and oral drug in the pleuromutilin class of antibiotics. The treatment has in vitro activity and has shown clinical efficacy against pathogens responsible for community-acquired bacterial pneumonia.

Lefamulin works through a unique method of action targeting a binding site on bacterial cells that is distinct from conventional antibiotics, resulting in a low risk of resistance and no cross-resistance with antibiotic classes frequently used in treating community-acquired bacterial pneumonia. Lefamulin’s efficacy was proven in two multicenter, global trials involving 1,289 CABP patients.

Schoeder said, “This new package size offers pharmacies an option to expand product availability in a cost-effective way to service their local patients and physicians by providing patients a convenient package that contains a complete 5-day course of oral treatment for CABP. Our community-based sales force is excited to communicate the availability of the 10-count oral pack – or ‘X’ pack to their target customers.”